Your main tasks
1. Serve as the main point of contact for customers in planning, executing, and following up on customer audits
2. Independently manage the internal coordination of customer audits, lead the front office during audits, and support post-audit activities
3. Take charge of or support front and back-office activities during regulatory authority audits
4. Representing IT & CSV topics during both customer and authority audits
5. Conduct root cause analyses and develop action plans as part of the internal deviation management system
6. Review and approve internal process instructions
7. Act as an internal contact person for quality-related topics across departments
Your profile
8. Degree in technical, scientific, or medical discipline, with additional qualifications in quality management
9. Several years of hands-on experience in quality management, ideally in the life sciences industry medical devices, pharmaceuticals, biotechnology)
10. Strong knowledge of relevant regulatory standards: ISO :6, EU-MDR, MDSAP, CFR. Familiarity with ISO/IEC :2 is a plus
11. Fluency in English is required; good German skills or a willingness to learn German is an advantage
Your benefits
Pension fund
Ypsomed covers % of the pension contributions
Mobility support
Charging stations, Swiss Half Fare Card, parking, close to public transport
Free sport facilities
Affordable or free gyms all over Switzerland
Family friendly
Financial contributions to childcare
Working hours
Shiftwork, annual working hours, part-time
FlexWork
Work where and when you want (in Switzerland)
Up-to-date work environment
Up-to-date production, offices, break areas Your Ypsomed work environment
Ypsomed - making the treatment of chronic diseases possible
More than 2, employees worldwide develop and produce injection and infusion systems for self-medication with the Ypsomed Group. We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treatment. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they are provided with the greatest possible quality of life.